WC Advantage 26 - SIZEWISE RENTALS, L.L.C.

Duns Number:967025602

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More Product Details

Catalog Number

-

Brand Name

WC Advantage 26

Version/Model Number

WCADV26

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K961514

Product Code Details

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Device Record Status

Public Device Record Key

888904d4-4660-45b0-80b5-ae8b01913dd5

Public Version Date

February 15, 2019

Public Version Number

1

DI Record Publish Date

January 15, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIZEWISE RENTALS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 130
2 A medical device with a moderate to high risk that requires special controls. 139